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Clinical Trial NCT07442747 for Parkinson's Disease, Deep Brain Stimulation is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS 36 Exercise-Based

Not yet recruiting
Clinical Trial NCT07442747 is an interventional study for Parkinson's Disease, Deep Brain Stimulation and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 36 participants. Led by The Cleveland Clinic, this study is expected to complete by 31 December 2029. The latest data from ClinicalTrials.gov was last updated on 2 March 2026.
Brief Summary
This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve P...Show More
Detailed Description
This study is investigating how aerobic exercise, specifically forced exercise (FE) and voluntary exercise (VE), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation (DBS). Over eight weeks, 36 participants will complete either a forced cycling program (where a motor helps them pedal faster than they could on their own) or a voluntary cycling progr...Show More
Official Title

Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease

Conditions
Parkinson's DiseaseDeep Brain Stimulation
Other Study IDs
NCT ID Number
NCT07442747
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-02
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Parkinson
Deep Brain Stimulation
Parkinson's disease
Deep Brain Stimulation Surgery
DBS
Exercise
exercise training
Parkinson disease
Parkinson's
Parkinson's Disease with Deep Brain Stimulation
Percept
Cycling
Aerobic
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalForced Exercise (FE)
Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolut...Show More
Exercise
Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.
ExperimentalVoluntary Exercise (VE)
Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and...Show More
Exercise
Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.
Baseline to EOT and Baseline to EOT+4 weeks
Relative Root Mean Square Error of a Grip Force Tracking Task
Participants are required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Relative root mean squared error quantifies deviation from the target force trajectory. Values are normalized for maximum target amplitude, with lower values indicating decreased error.
Baseline to EOT and Baseline to EOT+4 weeks
Local Field Potential Subthalamic Nucleus Beta at Rest
Normalized beta band activity is reported as the change in resting-state STN beta band (13-30Hz) power. Higher beta band suggests increased pathological electrical synchrony.
Baseline to EOT and Baseline to EOT+4 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Clinical diagnosis of Parkinson's disease
  • Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD
  • Clinically optimized DBS parameters for one month prior to enrollment
  • Ability to ambulate with or without an assistive device for 5 continuous minutes
  • Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments

  • Neurocognitive impairment that compromises the ability to provide informed consent

  • Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)

  • Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:

    1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.
    2. Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.

  • A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise

  • Current cardiac arrhythmia

The Cleveland Clinic logoThe Cleveland Clinic
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
Study Responsible Party
Jay Alberts, Principal Investigator, Staff, The Cleveland Clinic
Study Central Contact
Contact: MacKenzie Dunlap, 216-219-3949, [email protected]
No location data.